Tamponade for nasal cavities or sinus cavities

Abstract

A tamponade for nasal cavities or sinus cavities for tamponading a cavity of the nasal tract in the region of an ostium leading to the cavity with uniform force, comprising a thin-walled balloon which is made from a soft foil-like, only slightly expandable, smoothly folding polyurethane material, with a wall thickness in the range of 5 to 50 μm, which is already completely shaped with the required tamponade dimensions or greater at the time of production, and can therefore be expanded without application of filling pressure, and said balloon occupies the respective, generally irregular-shaped cavity and the ostium of same when in the filled condition, through the development of forces that are as uniform as possible on the structures exposed to the balloon in such a way that a distal segment of the balloon is located inside the cavity where a tamponade is to be applied, a proximal segment of the balloon is located upstream of the cavity and a transostial segment of the balloon extends through the ostium and connects the distal segment of the balloon to the proximal segment of the balloon, wherein the transostial segment of the balloon is tapered relative to the proximal and distal segments of the balloon in the deployed state of the balloon, and the nasal cavity or sinus cavity tamponade is anchored in the transition region and reliably secured in position.

The invention claimed is: 
     
       1. A tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ″;  11 ;  14 ;  19   a ,  19   b ) for tamponading a cavity of the nasal tract in the region of an ostium leading to the cavity with uniform force, comprising a thin-walled balloon ( 3 ), which is made from a smoothly folding polyurethane material, with a wall thickness in the range of 5 to 50 μm, which is already completely shaped with the required tamponade dimensions or greater at the time of production, and can therefore be expanded without application of filling pressure, and said balloon is configured to be placed relative to the cavity to be tamponaded in such a way that it occupies the respective, generally irregular-shaped cavity and the ostium of same when in a filled condition, through the development of uniform forces on the structures exposed to the balloon ( 3 ) in such a way that a distal segment ( 3   a ) of the balloon ( 3 ) is located inside the cavity where a tamponade is to be applied, a proximal segment ( 3   b ) of the balloon ( 3 ) is located upstream of the cavity and a transostial segment of the balloon ( 3 ) extends through the ostium and connects the distal segment ( 3   a ,  3   b ) of the balloon ( 3 ) to the proximal segment ( 3   b ) of the balloon ( 3 ), wherein the transostial segment of the balloon ( 3 ) is tapered relative to the proximal and distal segments ( 3   a ,  3   b ) of the balloon ( 3 ) in the deployed state of the balloon, and the tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) is anchored in the transition region and secured in position, wherein each of the distal segment ( 3   a ), the proximal segment ( 3   b ) and the tapered transostial segment is penetrated by a continuous tube ( 2 ), and the distal segment ( 3   a ) and the proximal segment ( 3   b ) are fixed to the tube ( 2 ). 
     
     
       2. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the balloon ( 3 ) is configured to be placed relative to the cavity to be tamponaded in such a way that it rests on the surface of the cavity and/or the ostium so as to form multiple, largely untensioned folds in a balloon sheath. 
     
     
       3. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the balloon ( 3 ) is configured to be placed relative to the cavity to be tamponaded in such a way that it rests on the surface of the cavity while largely avoiding the remaining residual spaces. 
     
     
       4. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that a sheath of the balloon ( 3 ) is untensioned in the region of the ostium and rests on a non-stretchable structure that is arranged there without tension-related pressure, and so the surface pressure exerted on the surface of the ostium corresponds to the surface pressure exerted on the surface of the cavity. 
     
     
       5. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the polyurethane material of the balloon ( 3 ) falls within the Shore durometer range of 80 Å to 95 Å. 
     
     
       6. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the balloon ( 3 ) has a wall thickness of 5 to 25 μm, in the vicinity of its largest diameter. 
     
     
       7. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the balloon ( 3 ) has a wall thickness of 10 to 20 μm, in the vicinity of its largest diameter. 
     
     
       8. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the balloon ( 3 ) consists of an optically transparent material, which permits the visual inspection of the tissue adjacent to the nasal cavity or sinus cavity tamponade ( 1 ;  14 ;  19   a ;  19   b ). 
     
     
       9. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the balloon ( 3 ) is configured to be placed relative to the cavity to be tamponaded in such a way that, in the transition region from the distal balloon segment ( 3   a ) lying within the cavity to be tamponaded to the region of the proximal balloon segment ( 3   b ) lying upstream of the cavity, the balloon ( 3 ) is provided with a taper ( 7 ,  13 ) or constriction, which anchors the tamponade ( 1 ;  14 ;  19   a ;  19   b ) in the transition region to the ostium and secures it in its position. 
     
     
       10. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 9 , characterized in that the diameter of the taper ( 7 ,  13 ) or constriction is at least 50% smaller than the diameter of the distally adjacent balloon segment. 
     
     
       11. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the distal segment ( 3   a ) of the balloon ( 3 ) is residually elongated such that it develops into the form of a folded and/or coiled, space-filling bundle when placed in the cavity to be filled and then inflated. 
     
     
       12. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the distal segment ( 3   a ) of the balloon ( 3 ) is two to ten times as long, or is two to five times as long, as the cavity to be tamponaded. 
     
     
       13. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the balloon ( 3 ) does not have an opening at its distal end or in that an opening there is close-sutured. 
     
     
       14. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the support tube ( 2 ) does not have an opening at its distal end or in that an opening there is close-sutured. 
     
     
       15. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 14 , characterized in that only the proximal end of the balloon ( 3 ) is applied to the support tube ( 2 ). 
     
     
       16. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 15 , characterized in that the support tube ( 2 ) or a filling tube extends into the distal segment ( 3   a ) of the balloon ( 3 ) that fills the sinus cavity and is sealingly connected there at its distal end to the distal end of the balloon ( 3 ). 
     
     
       17. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the support tube ( 2 ) is configured such that it is elastically deformable and/or has a wall thickness of 0.1 to 0.3 mm. 
     
     
       18. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the support tube ( 2 ) is molded with a rippled corrugation to improve its straightening properties. 
     
     
       19. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that the configuration of the proximal segment ( 3   b ) of the balloon ( 3 ) and its longitudinal extent can be limited by a sleeve element ( 8 ), which is pushed over the support tube ( 2 ) and the collapsed balloon ( 3 ). 
     
     
       20. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 1 , characterized in that it comprises a freely displaceable disk-like element ( 16 ) of a hard material with a continuous recess, which can be slipped over the balloon ( 3 ) and thus forms a hard structure in the region of a nasal ostium, on which the balloon ( 3 ) tapers and is thereby anchored, in the vicinity of its transition between the distal segment ( 3   a ) of the balloon ( 3 ) and the proximal segment ( 3   b ) of the balloon ( 3 ), in the region of a nasal ostium. 
     
     
       21. A tamponade ( 1 ;  1 ′;  1 ″;  1 ″;  11 ;  14 ;  19   a ,  19   b ) for a simultaneous tamponade of nasal cavities or sinus cavities in the left and right halves of the viscerocranium, each in the region of an ostium leading to the cavity with uniform force, comprising two thin-walled balloons ( 22   a ,  22   b ), which are made from a smoothly folding polyurethane material, with a wall thickness in the range of 5 to 50 μm, which is already completely shaped with the required tamponade dimensions or greater at the time of production, and can therefore be expanded without application of filling pressure, and said balloons ( 22   a ,  22   b ) are configured to be placed relative to the cavities to be tamponaded in such a way that each of said balloons ( 22   a ,  22   b ) occupies the respective, generally irregular-shaped cavity and the ostium of same when in a filled condition, through the development of uniform forces on the structures exposed to the balloon ( 22   a ,  22   b ) in such a way that a distal segment ( 3   a ) of each balloon ( 22   a ,  22   b ) is located inside the cavity where a tamponade is to be applied, a proximal segment ( 3   b ) of each balloon ( 22   a ,  22   b ) is located upstream of the cavity and a transostial segment of each balloon ( 22   a ,  22   b ) extends through the ostium and connects the distal segment ( 3   a ,  3   b ) of the balloon ( 22   a ,  22   b ) to the proximal segment ( 3   b ) of the balloon ( 22   a ,  22   b ), wherein the transostial segment of each balloon ( 22   a ,  22   b ) is tapered relative to the proximal and distal segments ( 3   a ,  3   b ) of the balloon ( 22   a ,  22   b ) in the deployed state of the balloon ( 22   a , 22   b ), and the tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) is anchored in the transition region and secured in position, wherein each of the distal segment ( 3   a ), the proximal segment ( 3   b ) and the tapered transostial segment of each balloon ( 22   a ,  22   b ) is penetrated by a continuous tube ( 21   a ,  21   b ), and wherein a free connection is established between the two balloons ( 22   a ,  22   b ), such as by means of a common fixation plate ( 16 ), which is configured to fix the intermediate anatomical structures in position while applying a homogenous force to both sides. 
     
     
       22. The tamponade for nasal cavities or sinus cavities ( 1 ;  1 ′;  1 ″;  1 ′″;  11 ;  14 ;  19   a ,  19   b ) according to  claim 21 , characterized in that one or both of the two balloons ( 22   a ,  22   b ) that are provided for simultaneously tamponading cavities in the left and right halves of the viscerocranium support a splint ( 23 ), or one splint each, consisting of a solid material, wherein two splints ( 23 ) of this type are arranged facing each other.